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# Accelerated Approval for Enhertu in Solid Tumors
- URL: https://www.fdaweb.com/accelerated-approval-for-enhertu-in-solid-tumors/
- Published: 2024-04-05T12:00:00.000Z
- Updated: 2026-09-14T14:27:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156717

FDA has granted Daiichi Sankyo an accelerated approval for Enhertu (fam-trastuzumab deruxtecan-nxki) for treating adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.

Approval was based on data from 192 adult patients with previously treated unresectable or metastatic HER2-positive (IHC 3+) solid tumors who were enrolled in one of three multicenter trials: DESTINY-PanTumor02 (NCT04482309), DESTINY-Lung01 (NCT03505710), and DESTINY-CRC02 (NCT04744831), according to an FDA release. (XXXINSERT LINKXX) In DESTINY-PanTumor02, the objective response rate (ORR) was 51.4% and median duration of response (DOR) was 19.4 months, the agency says. In DESTINY-Lung01, ORR was 52.9% and median DOR was 6.9 months. In DESTINY-CRC02, ORR was 46.9% and DOR was 5.5 months.

FDA says the most common adverse reactions experienced in 20% or more patients “including laboratory abnormalities were decreased white blood cell count, nausea, decreased hemoglobin, decreased neutrophil count, fatigue, decreased lymphocyte count, decreased platelet count, increased aspartate aminotransferase, increased alanine aminotransferase, increased blood alkaline phosphatase, vomiting, decreased appetite, alopecia, diarrhea, decreased blood potassium, constipation, decreased sodium, stomatitis, and upper respiratory tract infection.” A Boxed Warning on the risk of interstitial lung disease and embryo-fetal toxicity is included on the label.